SYDNEY, AUSTRALIA – Rasagiline is safe and efficacious as add-on therapy in patients with early Parkinson’s disease whose symptoms are not adequately controlled with dopamine agonist monotherapy, results from a randomized, double-blind placebo-controlled study suggest.
Data from the ANDANTE study showed that adding rasagiline (1 mg/day) to dopamine agonist therapy led to an additional mean 2.4-point reduction (P = .012; 95% CI, –4.3 to –0.5) in the Unified Parkinson's Disease Rating Scale (UPDRS) total score at 18 weeks, compared with placebo.
The 18-week phase IV study involved 328 patients with Parkinson’s disease whose symptoms were poorly controlled with dopamine agonist monotherapy.
Dr. Robert A. Hauser
Researchers also observed an additional mean 1.8-point improvement (P =.007; 95% CI, –3.1 to –0.5) in the UPDRS motor scores and a nonsignificant improvement in the activities of daily living (ADL) score, compared with placebo.
Lead author Dr. Robert Hauser, director of the University of South Florida’s Parkinson’s disease and movement disorder center in Tampa, said rasagiline – a selective, irreversible inhibitor of monoamine oxidase type B – is currently approved in the United States under the brand name Azilect as an adjunct to levodopa in patients with motor fluctuations, and as monotherapy earlier in the disease.
However, this study examined its use in patients whose symptoms were not being controlled by dopamine agonists but who had not yet started on levodopa.
"That was the question: ‘If patients are on a dopamine agonist and the disease is progressing and patients aren’t doing as well as you would like, is adding rasagiline an option? Is it helpful?’ " Dr. Hauser said in an interview at the international congress of Parkinson’s Disease and Movement Disorders.
Although the UPDRS total and motor score improvements were statistically significant, Dr. Hauser said that the clinical improvements were small and that perhaps rasagiline would be more effective if given even earlier in the disease as monotherapy.
"I think you get the best effect by starting it before the agonist," he said. "Still, if a patient comes to you on their agonist and they’re not doing well enough, it remains an option, but I think option No. 1 is get it going before the agonist."
There were no significant differences in adverse events or serious adverse events between the rasagiline and placebo groups, particularly with respect to sleepiness, sudden onset sleep, confusion, hallucinations, or orthostatic hypotension.
No impulse control disorders were observed, and six patients in the rasagiline group and five patients in the placebo group required rescue with levodopa during the study.
The study was supported by Teva Neuroscience (USA), Teva Pharmaceutical Industries (Israel), and H. Lundbeck (Denmark).